QA Specialist I - Product Release
Job Details
ADMA Biologics - Boca Raton, FL
Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for an QA Specialist I - Product Release!

The primary responsibility consists of review of controlled documents for accuracy and completeness prior to Quality Assurance (QA) release of product.

Qualifications
  • Understand the cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
  • Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
  • Review and release manufacturing batch records, and any additional supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data.
  • Perform usage decisions for batch release in SAP.
  • Work with IgG Manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues.
  • Perform period follow-up of ongoing deviations to assure timely closure of documentation and batch release.
  • Review and approve Certificates of Analysis for batch release in LIMS.
  • Review SOPs and documents from other departments and provide feedback as necessary.
  • Perform review and release of Plasma pools when required.
  • Initiate Deviations and Change Control as required.
  • Review, and revise QA SOPs.
  • Coordinate and perform any additional activities or projects assigned by QA Management.

Education Requirements:                   Bachelors Degree required.

 Experience Requirements:                 One to two years Quality Assurance (QA) experience in the pharmaceutical, biotechnology, or related industry. Experience with LIMS and SAP preferred.

In addition to competitive compensation, we offer a comprehensive benefits package including:

  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Pet Insurance
  • Company paid STD and LTD
  • Company Paid Holidays
  • 3 Weeks’ Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid shuttle to the Boca Tri-Rail station

     

ADMA Biologics  uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer

Florida Campus
Apply